FDA-Drug2018-04-04Class II

Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27

Paddock Laboratories, LLC.
Hazard

Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.

Sold states
Nationwide within the USA.
Affected count
52,596 bottles
Manufactured in
3940 Quebec Ave N, New Hope, MN, United States
Products
Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0608-2018

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